NEW DELHI: The fate of India's Rs 19,000 crore vaccine industry is hanging in balance.

An acid test on Monday will see a 16-member team from WHO ( World Health Organization) to review the country's all-important NRA ( National Regulatory Authority) or the Drug Controller's Office to see if it meets the norms laid down to ensure that the vaccines produced in India are safe and of high quality.

If NRA fails the test, export of all Indian vaccines will be stopped to 159 countries. Currently, India exports vaccines worth Rs 14,000 crore, while vaccines worth Rs 5,000 crore are used by the domestic market.

Around 12 Indian vaccine companies are qualified to supply vaccine to international agencies. Around 30 different types of vaccines — ranging from those against Hepatitis, measles and polio are being manufactured in India.

Major buyers and international procurement agencies like the Gates Foundation, Clinton Foundation, Unicef and GAVI will stop purchase of Indian vaccines meant for use across the world.

This is the first time the review will take place after 2009. India has failed three times earlier.

They will audit the CDSCO (Central Drugs Standard Control Organization) in New Delhi, the Central Drug Laboratory in Kasauli, where the country's vaccine testing is done besides conducting field visits in Chandigarh and Kerala to inspect how NRA handled adverse effects of vaccines used in the country's immunization programme.

DCGI (Drug Controller General of India) G N Singh said, "We are fully prepared for the audit and are confident to pass this test and become one of the most credible regulatory authority of the world. The audit will actually look at the competency capability of the Indian regulatory system. We have failed earlier. If we fail this time, we can no more be part of the procurement system of the major international agencies and our exports will be stopped."

He added, "The team will be here from December 10 to 14 and will see if India has in place quality management systems. It is critical we pass the test. Indian vaccines are saving children and adults across the planet and a halt in exports will hit them hard. At present, every third child in the world is being vaccinated against measles with an Indian vaccine. They will see how inspections are carried out, whether adverse events after immunization are properly handled and how market authorization is carried out."

The last time that such an audit was carried out was in 2009 when India actually passed the test. WHO sets out six critical control functions on which the NRA has to qualify. "We are presently exporting two-thirds of the vacc- ines manufactured while one-third is consumed inside India," Singh added.

WHO procures nearly 80% of the global supply of DPT and the BCG (bacille calmette-guerin) vaccine against tuberculosis, and almost 90% of measles vaccine from India.

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An acid test on Monday will see a 16-member team from WHO to review the country’s all-important NRA or the Drug Controller’s Office to see if it meets the norms laid down to ensure that the vaccines produced in India are safe and of high quality.